Local view for "http://purl.org/linkedpolitics/eu/plenary/2007-04-23-Speech-1-110"
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"en.20070423.17.1-110"2
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"Mr President, this evening we are debating a particularly important advance, which should enable future generations to benefit from high-technology medical treatments. European patients therefore need to be able to have access to these revolutionary products, on a non-discriminatory basis, because of the potential that they offer. It is also important to guarantee that these products are safe and effective.
The fact is that, without Community legislation, the situation varies from one country to another and is unfair for patients: some have access to products, when others have to go without. As you yourself said, Commissioner, in a situation such as this, there will be medical tourism. Therefore, if we are to overcome these obstacles, we need a clear, strict, framework encouraging investment and the growth of the biotech industry in Europe.
The technical section is therefore totally pointless in this context since, on account of subsidiarity, each Member State has the freedom to decide whether or not to ban this type of cell technology on its national market.
I particularly support the technical package that Mrs Roth-Behrendt has tabled in the form of amendments and that takes up all of the points of agreement that were reached during the various informal trialogues with the Council and the Commission. I truly hope that we vote in favour of this technical package because, by doing so, we will be able to reach an agreement at first reading and to fulfil patients’ expectations quicker.
I absolutely regret Amendments 3 and 17 tabled by the Committee on Legal Affairs. They simply prohibit any form of centralised authorisation for advanced therapy medicinal products derived from embryonic stem cells. I should like to point out that the aim of this text is to guarantee the safety of new therapies, while facilitating research and development and the authorisation of products derived from these advanced therapies. Amendments 3 and 17 put patients’ safety in real danger by excluding certain products from the very strict public heath requirements laid down by the regulation.
When patients’ safety is at stake, any form of discrimination is unacceptable. The implementation of a European technical framework, which patients and the industry have been awaiting for several years now, must not serve as a pretext for imposing any particular ideological point of view."@en1
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